Senior Manager, Audit Intelligence Coordinator

Role Summary

Senior Manager, Audit Intelligence Coordinator is responsible for planning audits in support of the BMS Competitive Compliance Audit Program, coordinating audits for internal sites, global suppliers, and entities such as CMOs, APIs, raw materials, and external labs. The role involves planning, organizing, and scheduling audit assignments in accordance with the global audit plan and supporting due diligence audits for clinical and commercial developments. It aims to enhance audit planning and execution using data-driven insights and integrates with internal processes such as QRM and Quality Council.

Responsibilities

• Develop and implement an annual audit plan using risk-based principles and data-driven decision-making.
• Plan, organize, and schedule audit assignments in collaboration with Audit Operations, and in accordance with the defined audit program and audit plan.
• Work with key stakeholders to maintain and update the annual audit plan for both planned and unplanned changes including routine, due diligence audits, pre-approval Inspection (PAI) readiness, Directed or For Cause, acquisitions, regulatory/agent distributors, labeling and inspection readiness.
• Enhance efficiency and simplify the management of the audit planning process by leveraging digital solutions such as automation and AI to advance strategic initiatives and focus on areas that drive the most impact.
• Communicate with stakeholders, Audit Operations, lead auditors and audit outsourcing partners regarding global audit plan changes in a timely manner.
• Periodically review and update the audit plan using current compliance, quality, data intelligence, and risk-based principles.
• Ensure exceptions to the global audit plan are properly documented, justified, and approved.
• Stay abreast of current and updated regulations affecting the Audit program and modify plans, policies, and directives to ensure compliance with changing regulatory requirements.
• Maintain and continuously improve governing procedures and processes.
• Develop and utilize robust metrics and analysis to monitor the health and performance of the Audit program, enhance audit planning, maximize audit effectiveness, and measure outcomes/impacts of audits.
• Elevate and refine the audit program through vigilant monitoring and data-driven insights, in partnership with Competitive Compliance.
• Utilize internal processes such as Quality Risk Management (QRM) and the Quality Council to communicate signals and trends, mitigate risks, and drive continuous improvement.
• Obtain support from the business to deal with supplier audit scheduling issues, including audit refusals and audit fees.

Qualifications

• A minimum of five (5) years' experience in the biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory position or with a regulatory health authority; strong auditing, metrics, analysis, and business analytics background.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.
• Proven ability to understand complex processes/problems and propose alternate solutions.
• Innovation, flexibility, adaptability to changing objectives and priorities.
• Strong communication, collaboration, negotiation, problem solving, and interpersonal skills.
• Experience working in a matrixed organization with diverse teams and ability to influence across boundaries.
• Ability to manage multiple projects with minimal supervision and prioritize workloads.
• In-depth knowledge of Global Health Authority regulations and quality systems principles as applied to the pharmaceutical industry.
• Proven track record of cross-network collaboration to drive positive impact for patients.
• Strong understanding of performance/health program monitoring and data quality assurance principles.
• Effective communication across levels and formats (presentations, proposals, reports, meetings).
• Proficiency in data analytics and advanced analytics tools.

Education

• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.